Saxagliptin recalls

The FDA has published 2 recalls involving Saxagliptin since 2025. The latest was reported on 16 Apr 2025. Most were for manufacturing (cgmp) deviations. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2025

Last 12 months0reported

Class I00% of total

Ongoing2latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 2 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why saxagliptin is recalled

Manufacturing (CGMP) Deviations2100%

Companies

Glenmark Pharmaceuticals Inc., USA2100%

By year

20252100%

Ongoing saxagliptin recalls

2 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Saxagliptin Tablets 5mg, a) recalled by Glenmark PharmaceuticalsSaxagliptin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Saxagliptin Tablets, USP, 2.5mg, a) recalled by Glenmark PharmaceuticalsSaxagliptin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide

All saxagliptin recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Saxagliptin Tablets 5mg, a) recalled by Glenmark PharmaceuticalsSaxagliptin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Saxagliptin Tablets, USP, 2.5mg, a) recalled by Glenmark PharmaceuticalsSaxagliptin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Saxagliptin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.